JUMP START, MODEL 970300

K021168 · Medical Research Laboratories, Inc. · MKJ · Jun 26, 2002 · Cardiovascular

Device Facts

• Record ID: K021168
• Device Name: JUMP START, MODEL 970300
• Applicant: Medical Research Laboratories, Inc.
• Product Code: MKJ · Cardiovascular
• Decision Date: Jun 26, 2002
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic, Pediatric

Indications for Use

The JUMP START is intended to be used to treat patients in cardiopulmonary arrest. It is intended for use in either in-hospital or out-of-hospital arrests. It is intended for use by personnel who are authorized by a physician/medical director, and who have the following training and skills: - American Heart Association Heartsaver course, American Red Cross CPR / AED course, or equivalent - Training in the use of the MRL JUMP START + It should only be used on patients who are unconscious, pulseless, and not breathing spontaneously. The biphasic waveform employed by the JUMP START has not been clinically tested on pediatric patients The device has not been evaluated for cardioversion of atrial fibrillation or direct (internal) cardiac defibrillation. It should not be used on pediatric patients less than 8 years old.

Device Story

Jump Start (Model 970300) is an automated external defibrillator (AED) used for treating cardiopulmonary arrest. Operated by trained personnel (AHA Heartsaver/Red Cross CPR/AED certified) in in-hospital or out-of-hospital settings. Device monitors patient cardiac rhythm; delivers biphasic electrical shocks to restore normal heart rhythm in pulseless, unconscious patients. Output guides clinical intervention during cardiac emergencies. Benefits include rapid, automated rhythm analysis and defibrillation therapy to improve survival outcomes in sudden cardiac arrest.

Clinical Evidence

No clinical data provided. The document notes the biphasic waveform has not been clinically tested on pediatric patients.

Technological Characteristics

Automated External Defibrillator (AED) utilizing a biphasic waveform for defibrillation. Designed for external use only. Device is intended for use by trained laypersons or medical personnel.

Indications for Use

Indicated for patients in cardiopulmonary arrest who are unconscious, pulseless, and not breathing spontaneously. Contraindicated for pediatric patients less than 8 years old. Not indicated for cardioversion of atrial fibrillation or internal cardiac defibrillation.

Regulatory Classification

Identification

An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 6 2002

Medical Research Laboratories, Inc. c/o Mr. Joel Orlinsky 1000 Asbury Drive Buffalo Grove, IL 60089

Re: K021168

> Jump Start (Model 970300) Regulation Number: 870.1025 Regulation Name: Automated External Defibrillator Regulatory Class: III (three) Product Code: 74 MKJ Dated: April 10, 2002 Received: April 11, 2002

Dear Mr. Orlinsky:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Joel Orlinsky

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Attachment III

.510(k) Number (if Known): ____________________________________________________________________________ 68

Device Name: JUMP START

Indications For Use:

The JUMP START is intended to be used to treat patients in cardiopulmonary arrest. It is intended for use in either in-hospital or out-of-hospital arrests.

It is intended for use by personnel who are authorized by a physician/medical director, and who have the following training and skills:

- American Heart Association Heartsaver course, American Red Cross CPR / � AED course, or equivalent
- Training in the use of the MRL JUMP START +

It should only be used on patients who are unconscious, pulseless, and not breathing spontaneously. The biphasic waveform employed by the JUMP START has not been clinically tested on pediatric patients The device has not been evaluated for cardioversion of atrial fibrillation or direct (internal) cardiac defibrillation. It should not be used on pediatric patients less than 8 years old.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODR)

ん
Division of Cardiovascular & Respiratory Devices
510(k) Number Ko 21168
scular &

Prescription Use (Per 21 CFR 801.109

OR

Over-The-Counter Use

(Optional Format 1-2-96)